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Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88

[Docket No. CDC-2012-0007; NIOSH-257]

RIN 0920-AA49

World Trade Center Health Program; Addition of Certain Types of Cancer to the List of WTC-Related Health Conditions

AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Final rule.
SUMMARY: Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. The WTC Health Program, which is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks. In accordance with WTC Health Program regulations, which establish procedures for adding a new condition to the list of covered health conditions, this final rule adds to the List of WTC-Related Health Conditions the types of cancer proposed for inclusion by the notice of proposed rulemaking.
DATES: This final rule is effective October 12, 2012.
FOR FURTHER INFORMATION CONTACT: Frank J. Hearl, PE, Chief of Staff, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Patriots Plaza, Suite 9200, 395 E St. SW., Washington, DC 20201. Telephone: (202) 245-0625 (this is not a toll-free number). Email:WTCpublicinput@cdc.gov.
SUPPLEMENTARY INFORMATION:

This notice of final rulemaking is organized as follows:

I. Executive Summary II. Public Participation III. Background A. WTC Health Program Statutory Authority B. Need for Rulemaking C. Review of Scientific Evidence D. Physician Determination and Program Certification of WTC-Related Health Conditions Including Types of Cancer E. Effects of Rulemaking on Federal Agencies IV. Methods Used by the Administrator To Determine Whether To Add Cancer or Types of Cancer to the List of WTC-Related Health Conditions V. Administrator's Determination Concerning Petition 001: Addition of Cancers to the List of WTC-Related Health Conditions, 42 CFR 88.1 VI. Summary of Final Rule and Response to Public Comments VII. Regulatory Assessment Requirements A. Executive Order 12866 and Executive Order 13563 B. Regulatory Flexibility Act C. Paperwork Reduction Act D. Small Business Regulatory Enforcement Fairness Act E. Unfunded Mandates Reform Act of 1995 F. Executive Order 12988 (Civil Justice) G. Executive Order 13132 (Federalism) H. Executive Order 13045 (Protection of Children From Environmental Health Risks and Safety Risks) I. Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use) J. Plain Writing Act of 2010 VIII. Final Rule I. Executive Summary A. Purpose of Regulatory Action

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program within the Department of Health and Human Services (HHS). The PHS Act requires the WTC Program Administrator (Administrator) to conduct rulemaking to propose the addition of a health condition to the List of WTC-Related Health Conditions (List) codified in 42 CFR 88.1 regardless of whether the Administrator proposes to add a health condition based on the findings from periodic reviews of cancer,1 a request from a petition, or a determination made at the Administrator's discretion that a proposed rule adding a condition should be initiated. Following a petition to add cancer or certain types of cancer to the List and a recommendation by the WTC Health Program's Scientific/Technical Advisory Committee (STAC), the Administrator is following the procedures established in 42 CFR 88.17 to add the types of cancer recommended by the STAC to the List in § 88.1.

1See PHS Act, Title XXXIII sec. 3312(a)(5).

B. Summary of Major Provisions

This rule modifies the List of WTC-Related Health Conditions in 42 CFR 88.1 to add the following conditions (types of cancer identified by ICD-10 code are specified in the discussion below):

Malignant neoplasms of the lip, tongue, salivary gland, floor of mouth, gum and other mouth, tonsil, oropharynx, hypopharynx, and other oral cavity and pharynx Malignant neoplasm of the nasopharynx Malignant neoplasms of the nose, nasal cavity, middle ear, and accessory sinuses Malignant neoplasm of the larynx Malignant neoplasm of the esophagus Malignant neoplasm of the stomach Malignant neoplasm of the colon and rectum Malignant neoplasm of the liver and intrahepatic bile duct Malignant neoplasms of the retroperitoneum and peritoneum, omentum, and mesentery Malignant neoplasms of the trachea; bronchus and lung; heart, mediastinum and pleura; and other ill-defined sites in the respiratory system and intrathoracic organs Mesothelioma Malignant neoplasms of the soft tissues (sarcomas) Malignant neoplasms of the skin (melanoma and non-melanoma), including scrotal cancer Malignant neoplasm of the breast Malignant neoplasm of the ovary Malignant neoplasm of the urinary bladder Malignant neoplasm of the kidney Malignant neoplasms of renal pelvis, ureter and other urinary organs Malignant neoplasms of the eye and orbit Malignant neoplasm of the thyroid Malignant neoplasms of the blood and lymphoid tissues (including, but not limited to, lymphoma, leukemia, and myeloma) Childhood cancers Rare cancers

The Administrator developed a hierarchy of methods (detailed in Section IV of this preamble) for determining which cancers to propose for inclusion on the List of WTC-Related Health Conditions.

C. Costs and Benefits

Annual costs, benefits, and transfers of this rule are listed in the table below. This analysis estimates the impact on WTC Health Program costs using the number of persons currently enrolled in the Program as responders and survivors and assumes that the rate of cancer in the population will be equal to the U.S. population average rate. An alternative analysis considers the impact on costs if the Program enrolls additional persons up to the Program's statutory limits, and that the expanded population experiences a 21 percent higher rate of cancer than the U.S. population average. The basis for these assumptions is explained in detail in the preamble of this rulemaking (see Section VII.A., below).

Although we cannot quantify the benefits associated with the WTC Health Program, enrollees with cancer are expected to experience a higher quality of care than they would in the absence of the Program. Mortality and morbidity improvements for cancer patients expected to enroll in the WTC Health Program are anticipated because barriers may exist to access and delivery of quality health care services for cancer patients in the absence of the services provided by the WTC Health Program. HHS anticipates benefits to cancer patients treated through the WTC Health Program, who may otherwise not have access to health care services, to accrue in 2013. Starting in 2014, continued implementation of the Affordable Care Act will result in increased access to health insurance and improved health care services for the general responder and survivor population that currently is uninsured.

Estimated annual WTC Health Program costs, transfers, and benefits, 55,000 responders and 5,000 survivors at U.S. population cancer rate, and 80,000 responders and 30,000 survivors at U.S. population cancer rate + 21 percent, 2013-2016, 2011$ Societal Costs for 2013, 2011$ Annualized Transfers for 2013-2016, 2011$ Based on the 16.3 percent of general responders and survivors who are expected to be uninsured Discounted at 7 percent Discounted at 3 percent Cancer Rate Cancer Rate U.S. Average U.S. + 21% U.S. Average U.S. + 21% 55,000 Responders $1,648,706 $10,172,308 5,000 Survivors 271,427 1,572,907 Colorectal and Breast Screening 204,491 713,321 60,000 Total 2,124,624 12,458,535 80,000 Responders 2,631,100 19,912,464 30,000 Survivors 1,970,560 12,124,118 Colorectal and Breast Screening 417,521 1,271,478 110,000 Total 5,019,182 33,308,060 Qualitative benefits Although we cannot quantify the benefits associated with the WTC Health Program, enrollees with cancer are expected to experience a higher quality of care than they would in the absence of the Program. Mortality and morbidity improvements for cancer patients expected to enroll in the WTC Health Program are anticipated because barriers may exist to access and delivery of quality health care services for cancer patients in the absence of the services provided by the WTC Health Program. HHS anticipates benefits to cancer patients treated through the WTC Health Program, who may otherwise not have access to health care services, to accrue in 2013. Starting in 2014, continued implementation of the Affordable Care Act will result in increased access to health insurance and improved health care services for the general responder and survivor population that currently is uninsured. II. Public Participation

On June 13, 2012 HHS published a notice of proposed rulemaking (77 FR 35574) proposing to add certain cancers to the List of WTC-Related Health Conditions. HHS invited interested persons or organizations to submit written views, opinions, recommendations, and data on any topic related to the proposed rule. The Administrator specifically sought comments on the methodology proposed to evaluate evidence for the addition of types of cancer to the List of WTC-Related Health Conditions; the proposed cost estimates; information or published studies about the type of welding and/or metal cutting that occurred at any of the disaster sites and information about exposure to ultraviolet light; and information or published studies about the scheduling of work hours or shiftwork occurring at any of the disaster sites.

HHS received 27 substantive submissions to the docket for this rulemaking. Commenters included labor unions that represent WTC responders, including police department members and others who conducted rescue, recovery, and clean-up; private citizens, including WTC responders; the spouse of a responder; survivors; relatives of victims and survivors; physicians who have treated WTC responders; health care professionals with no stated experience treating 9/11-exposed patients; health and research organizations; the WTC Health Program Survivors Steering Committee; a chemical supplier; and an elected official. Additionally, one private citizen submitted a comment that was outside the scope of this rulemaking. The substantive comments are described below, followed by the Administrator's response to each (see Section V., below).

III. Background A. WTC Health Program Statutory Authority

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347), amended the PHS Act to add Title XXXIII2 establishing the WTC Health Program within HHS. The WTC Health Program provides medical monitoring and treatment benefits to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks.

2Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm to 300mm-61. Those portions of the Zadroga Act found in Titles II and III of Public Law 111-347 do not pertain to the WTC Health Program and are codified elsewhere.

All references to the Administrator in this notice mean the NIOSH Director or his or her designee. Section 3312(a)(6) of the PHS Act requires the Administrator to conduct rulemaking to propose the addition of a health condition to the List of WTC-Related Health Conditions codified in 42 CFR 88.1.

B. Need for Rulemaking

The PHS Act requires the Administrator to conduct rulemaking to propose the addition of a health condition to the List of WTC-Related Health Conditions codified in 42 CFR 88.1 regardless of whether the Administrator proposes to add a health condition based on the findings from periodic reviews of cancer,3 a request from a petition, or a determination made at the Administrator's discretion that a proposed rule adding a condition should be initiated. On September 7, 2011, the Administrator received a written petition to add a health condition to the List of WTC-Related Health Conditions (Petition 001). Petition 001 requested that the Administrator “consider adding coverage for cancer” to the List in § 88.1.4

3See PHS Act, sec, 3312(a)(5).

4Maloney CB, Nadler J, King PT, Schumer CE, Gillibrand KE, Rangel CB, Velazquez NM, Grimm MG, Clarke YD. [2011]. Letter from Congress to John Howard, MD, Director, National Institute for Occupational Safety and Health (NIOSH). WTC Health Program Petition 001. Petition 001 is included in the docket for this rulemaking. Seehttp:www.regulations.govandhttp://www.cdc.gov/niosh/docket/archive/docket257.html.

On October 5, 2011, the Administrator formally exercised his option to request a recommendation from the STAC regarding the petition (PHS Act, sec. 3312(a)(6)(B)(i); 42 CFR 88.17(a)(2)(i)). The Administrator requested that the STAC “review the available information on cancer outcomes associated with the exposures resulting from the September 11, 2001, terrorist attacks, and provide advice on whether to add cancer, or a certain type of cancer, to the List specified in the Zadroga Act.”5 In response, the STAC submitted its recommendation on April 2, 2012, and the Administrator issued a notice of proposed rulemaking on June 13, 2012. The background to this rulemaking and a discussion of the STAC's recommendation are provided in the notice of proposed rulemaking published on June 13, 2012 (77 FR 35574).

5Howard J [2011]. October 5, 2011 Letter from John Howard, MD, Director, National Institute for Occupational Safety and Health (NIOSH) to the WTC Health Program Scientific/Technical Advisory Committee. This letter is included in the docket for this rulemaking. Seehttp:www.regulations.gov and http://www.cdc.gov/niosh/docket/archive/docket257.html.

C. Review of Scientific Evidence

As reviewed in detail in the June 13, 2012 notice of proposed rulemaking, theAdministrator considered data from five information sources to decide whether to propose the addition of cancers to the List of WTC-Related Health Conditions: (1) Peer-reviewed studies published in the scientific literature, including environmental sampling data, epidemiologic studies on the 9/11-exposed populations, and studies providing evidence of a causal relationship between a type of cancer and a condition already on the List of WTC-Related Health Conditions;6 (2) findings and recommendations solicited from the WTC Clinical Centers of Excellence and Data Centers, the WTC Health Registry at the New York City Department of Health and Mental Hygiene, and the New York State Department of Health; (3) information from the public solicited through a request for information published in theFederal Registeron March 8, 2011 and March 29, 2011; (4) the findings of the National Toxicology Program (NTP) in the National Institute of Environmental Health Sciences, HHS,7 as well as the World Health Organization's International Agency for Research on Cancer (IARC);8 and (5) findings from other sources of information relevant to 9/11 exposures, including the expert judgment and personal experiences of STAC members, and comments from the public.

6The July 2011, First Periodic Review of the Scientific and Medical Evidence Related to Cancer for the World Trade Center Health Program (First Periodic Review), requested by the Administrator, was included among the information considered. NIOSH [2011]. First Periodic Review of Scientific and Medical Evidence Related to Cancer for the World Trade Center Health Program. NIOSH Publication No. 2011-197.http://www.cdc.gov/niosh/docs/2011-197/pdfs/2011-197.pdf/.Accessed April 18, 2012. As required by sec.3312(a)(5)(A) of the PHS Act, the review considered ”all available scientific and medical evidence, including findings and recommendations of Clinical Centers of Excellence, published in peer-reviewed journals to determine if, based on such evidence, cancer or a certain type of cancer should be added to the applicable list of WTC-related health conditions.” At the time of publication, the First Periodic Review identified only one peer-reviewed article addressing the association of exposures arising from the September 11, 2001, terrorist attacks and cancer in responders and survivors, and two publications that used models to estimate the risk of cancer among residents in Lower Manhattan. Unlike the explicit standard prescribed for periodic reviews of cancer under sec. 3312(a)(5)(A), sec. 3312(a)(6) of the PHS Act does not specify the sources upon which the Administrator may base his or her determination to propose the addition of cancer or types of cancer to the List of WTC-Related Health Conditions.

7NTP Report on Carcinogens (RoC).http://ntp.niehs.nih.gov/?objectid=72016262-BDB7-CEBA-FA60E922B18C2540.Accessed May 9, 2012.

8WHO International Agency for Research on Cancer (IARC).http://monographs.iarc.fr/.Accessed May 8, 2012.

In September 2011, an epidemiologic study by Rachel Zeig-Owens and colleagues (hereafter, “Zeig-Owens”), “identified a modest effect of WTC exposure for all cancers combined by comparing the ratios in the exposed group [of Fire Department of New York City firefighters] to those in the non-exposed group.”9 This publication led to the submission of Petition 001. The Administrator requested that the STAC provide a recommendation on Petition 001. The STAC established evidentiary criteria and assessed the weight of the available scientific evidence provided by information sources (1), (4), and (5), described above. The STAC found support for including a number of types of cancer based in part on evidence of increased risk reported in Zeig-Owens. The STAC also included a number of types of cancer based on the professional judgment of STAC members with scientific expertise, on the personal experience of some of the STAC members who were themselves WTC responders or survivors, and on comments made by members of the public.

9Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K, Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York City Firefighters After the 9/11 Attacks: An Observational Cohort Study. Lancet. 378(9794):898-905.

Following review of the STAC recommendation, the Administrator agreed with the STAC that individual exposure assessment information arising from the terrorist attacks is extremely limited and that its absence impairs definitive scientific analysis of the relationship between exposures arising from the attacks and the occurrence of any specific type of cancer. The Administrator also found that multiple epidemiologic studies of cancer in exposed responders and survivors which definitively support an association between 9/11 exposures and specific types of cancer that would meet generally well-accepted criteria indicating that the association is a causal one are not currently available.

After considering various approaches to evaluate the available scientific evidence (see discussion in the June 13, 2012 notice of proposed rulemaking), the Administrator has adopted the methodology outlined in the proposed rule and set out in Section IV below. This methodology follows on criteria used by the STAC in its recommendation. Using the methodology, the Administrator adds the types of cancer, identified in Section V below, to the List of WTC-Related Health Conditions.

D. Physician Determination and Program Certification of WTC-Related Health Conditions Including Types of Cancer

In order for an individual enrolled as a WTC responder or survivor to obtain coverage for treatment of any health condition on the List of WTC-Related Health Conditions, including any type of cancer added to the List, a two-step process must be satisfied. First, a physician at a Clinical Center of Excellence (CCE) or in the nationwide provider network must make a determination that the particular type of cancer for which the responder or survivor seeks treatment coverage is both on the List of WTC-Related Health Conditions and that exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 11, 2001, terrorist attacks is substantially likely to be a significant factor in aggravating, contributing to, or causing the type of cancer for which the responder or survivor seeks treatment coverage.10 Pursuant to 42 CFR 88.12(a), the physician's determination must be based on the following: (1) An assessment of the individual's exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, attacks; and (2) the type of symptoms reported and the temporal sequence of those symptoms. In addition, the statute requires that all physician determinations are reviewed by the Administrator and are certified for treatment coverage unless the Administrator determines that the condition is not a health condition on the List of WTC-Related Health Conditions or that the exposure resulting from the September 1, 2001, terrorist attacks is not substantially likely to be a significant factor in aggravating, contributing to, or causing the condition. Thus, the inclusion of a condition on the List of WTC-Related Health Conditions, in and of itself, does not guarantee that a particular individual's condition will be certified as eligible for treatment. Responders and survivors denied certification have a right to appeal the denial of certification.

10See PHS Act, sec.3312(a)(1); 42 U.S.C. 300mm-22(a)(1).

E. Effects of Rulemaking on Federal Agencies

Title II of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347) reactivated the September 11, 2001 Victim Compensation Fund (VCF). Administered by the U.S. Department ofJustice (DOJ), the VCF provides compensation to any individual or representative of a deceased individual who was physically injured or killed as a result of the September 11, 2001, terrorist attacks or during the debris removal. Eligibility criteria for compensation by the VCF include a list of presumptively covered health conditions, which are physical injuries determined to be WTC-related health conditions by the WTC Health Program. Pursuant to DOJ regulations, the VCF Special Master is required to update the list of presumptively covered conditions when the List of WTC-Related Health Conditions in 42 CFR 88.1 is updated.11 (See also Section VII.A., Effects on Other Agency Programs, below.)

1128 CFR 104.21.

IV. Methods Used by the Administrator To Determine Whether To Add Cancer or Types of Cancer to the List of WTC-Related Health Conditions

For the reasons discussed above and detailed in the notice of proposed rulemaking published in theFederal Registeron June 13, 2012, the Administrator developed the following hierarchy of methods for determining whether to add cancer or types of cancer to the List of WTC-Related Health Conditions in 42 CFR 88.1. In determining whether to propose that a type of cancer be included on the List, a review of the evidence must demonstrate fulfillment of at least one of the following four methods:

Method 1. Epidemiologic Studies of September 11, 2001 Exposed Populations.A type of cancer may be added to the List if published, peer-reviewed epidemiologic evidence supports a causal association between 9/11 exposures and the cancer type. The following criteria extrapolated from the Bradford Hill criteria will be used to evaluate the evidence of the exposure-cancer relationship:

Strengthof the association between a 9/11 exposure and a health effect (including the magnitude of the effect and statistical significance);

consistencyof the findings across multiple studies;

biological gradient,or dose-response relationships between 9/11 exposures and the cancer type; and

plausibilityandcoherencewith known facts about the biology of the cancer type.

If only a single published epidemiologic study is available for review, the consistency of findings cannot be evaluated and strength of association will necessarily place greater emphasis on statistical significance than on the magnitude of the effect.

Method 2. Established Causal Associations.A type of cancer may be added to the List if there is well-established scientific support published in multiple epidemiologic studies for a causal association between that cancer and a condition already on the List of WTC-Related Health Conditions.

Method 3. Review of Evaluations of Carcinogenicity in Humans.A type of cancer may be added to the List only ifbothof the following criteria for Method 3 are satisfied:

3A. Published Exposure Assessment Information.9/11 agents werereportedin a published, peer-reviewed exposure assessment study of responders or survivors who were present in either the New York City disaster area as defined in 42 CFR 88.1, or at the Pentagon, or in Shanksville, Pennsylvania; and

3B. Evaluation of Carcinogenicity in Humans from Scientific Studies.NTP has determined that the 9/11 agent isknown to be a human carcinogenor isreasonably anticipated to be a human carcinogen,and IARC has determined there issufficientorlimitedevidence that the 9/11 agent causes a type of cancer.

Method 4. Review of Information Provided by the WTC Health Program Scientific/Technical Advisory Committee.A type of cancer may be added to the List if the STAC has provided a reasonable basis for adding a type of cancer and the basis for inclusion does not meet the criteria for Method 1, Method 2, or Method 3.

The following schematic illustrates the methodology proposed in the notice of proposed rulemaking and established in this final rule.

BILLING CODE 4161-17-P ER12SE12.012 BILLING CODE 4161-17-C V. Administrator's Determination Concerning Petition 001: Addition of Cancers to the List of WTC-Related Health Conditions, 42 CFR 88.1

Using the evidentiary standards established above for inclusion of a cancer on the List of WTC-Related Health Conditions in 42 CFR 88.1, and in accordance with the review of evidence discussed in the notice of proposed rulemaking published in theFederal Registeron June 13, 2012, the Administrator adds the specific types of cancers in the list below to the List of WTC-Related Health Conditions in 42 CFR 88.1. In the list below, the name of the cancer is followed by its ICD-10 code12 as well as the method used to include the cancer. A more detailed list, including sub-codes, is included in Table 1 in the regulatory text below.

12WHO (World Health Organization) [1997]. International Classification of Diseases, Tenth Revision. Geneva: World Health Organization. The International Classification of Diseases (ICD) is used to code and classify injuries and diseases and their signs, symptoms, and external causes for statistical presentation, disease analysis, hospital records indexing, and medical billing reimbursement.

Malignant neoplasms of the lip [C00], tongue [C01, C02], salivary gland [C07, C08], floor of mouth [C04], gum and other mouth [C03, C05, C06], tonsil [C09], oropharynx [C10], hypopharynx [C12, C13], other oral cavity and pharynx [C14] (Method 3) Malignant neoplasm of the nasopharynx [C11] (Method 3) Malignant neoplasms of the nasal cavity [C30] and accessory sinuses [C31] (Method 3) Malignant neoplasm of the larynx [C32] (Method 3) Malignant neoplasms of the esophagus [C15] (Method 2) Malignant neoplasm of the stomach [C16] (Method 3) Malignant neoplasms of the colon (and rectum) [C18, C19, C20, C26.0] (Method 3) Malignant neoplasms of the liver and intrahepatic bile duct [C22] (Method 3) Malignant neoplasms of the retroperitoneum and peritoneum [C48] (Method 3) Malignant neoplasms of the trachea [C33]; bronchus and lung [C34]; heart, mediastinum and pleura [C38]; and other ill-defined sites in the respiratory system and intrathoracic organs [C39] (Method 3) Mesothelioma [C45] (Method 3) Malignant neoplasm of peripheral nerves and autonomic nervous system [C47) and malignant neoplasm of other connective and soft tissue [C49] (Method 3) Other malignant neoplasms of skin (non-melanoma) [C44] (Method 3), malignant melanoma of skin [C43] (Method 4), and malignant neoplasm of scrotum [C63.2] (Methods 3) Malignant neoplasm of the breast [C50] (Method 4) Malignant neoplasm of the ovary [C56] (Method 3) Malignant neoplasm of the urinary bladder [C67] (Method 3) Malignant neoplasm of the kidney [C64] (Method 3) Malignant neoplasm of the renal pelvis, ureter and other urinary organs [C65, C66 and C68] (Method 3) Malignant neoplasm of the eye and orbit [C69] (Method 4) Malignant neoplasm of thyroid gland [C73] (Method 3) Hodgkin's disease [C81]; follicular [nodular] non-Hodgkin lymphoma [C82]; diffuse non-Hodgkin lymphoma [C83]; peripheral and cutaneous T-cell lymphomas [C84]; other and unspecified types of non-Hodgkin lymphoma [C85]; malignant immunoproliferative diseases [C88]; multiple myeloma and malignant plasma cell neoplasms [C90]; lymphoid leukemia [C91]; myeloid leukemia [C92]; monocytic leukemia [C93]; other leukemias of specified cell type [C94]; leukemia of unspecified cell type [C95]; other and unspecified malignant neoplasms of lymphoid, hematopoietic and related tissue [C96] (Method 3) Childhood Cancers [any type of cancer occurring in a person less than 20 years of age] (Method 4) Rare Cancers [any type of cancer affecting populations smaller than 200,000 individuals in the United States,i.e., occurring at an incidence rate less than 0.08 percent of the U.S. population] (Method 4) VI. Summary of Final Rule and Response to Public Comments

The final rule amends the definition of “List of WTC-Related Health Conditions” in 42 CFR 88.1, to include the types of cancer referenced above in Section V, which are the cancers proposed in the June 13, 2012, notice of proposed rulemaking (77 FR 35574). Table 1 in the regulatory text describes types of cancers included in 42 CFR 88.1 and identifies each by ICD-10 code. Because the ICD-10 modification will not be used by the U.S. healthcare system until October 1, 2014, the corresponding ICD-9 codes for the included cancer types are also provided in Table 1 in the regulatory text.

The effect of this amendment is that, for the types of cancers added, an enrolled WTC responder, certified-eligible survivor, or screening-eligible survivor may seek certification of a physician's determination that the September 11, 2001, terrorist attacks were substantially likely to be a significant factor in aggravating, contributing to, or causing the individual's cancer. As discussed above, if the condition is certified by the Administrator, the individual may seek treatment and monitoring of this condition under the WTC Health Program.

As described in the Public Participation section, above, the Administrator received 27 substantive submissions from the public on the methodology and the types of cancers proposed in the June 13, 2012Federal Registernotice (77 FR 35574). Upon consideration of the public comments, the Administrator has determined not to amend the methodology or the list of cancers in Table 1 of the regulatory text proposed in the June 13, 2012 notice of proposed rulemaking (77 FR 35574). The comments are summarized below, followed by the Administrator's response to each.

Comment:The Administrator received 12 comments in support of adding the proposed types of cancer to the List of WTC-Related Health Conditions. Some commenters expressed support for the specific methodologies proposed by the Administrator, including the use of the NTP and the IARC designations (Method 3). Commenters noted that requiring conclusive epidemiological evidence to add cancers to the List may not be fair to responders and survivors who are ill now, given the time required to collect sufficient data and publish studies in peer-reviewed journals. Some commenters correctly pointed out that an individual's diagnosis must be determined to be related to 9/11 exposure by a WTC Health Program physician and then certified by the Administrator in order for that individual to receive treatment through the Program. Some commenters wrote in support of specific types of cancer for inclusion.

Response:The Administrator agrees that establishing a broad continuum of decision-making methods is important to ensure that WTC responders and survivors receive care for health conditions associated with the September 11, 2001, terrorist attacks.

Comment:The Administrator received three comments opposing the addition of the proposed types of cancer to the List of WTC-Related Health Conditions using the methodology established in this final rule. One commenter concurred with the use ofMethods 1 and 2, but stated that Methods 3 and 4 “leave the door open for speculation and anecdotal evidence to influence the decision process.” Two commenters questioned the use of the Zeig-Owens13 study by the STAC to recommend the addition of types of cancer to the List,e.g., thyroid and melanoma, mentioning the preliminary nature of the results and that the recommended types of cancer do not meet the traditional level of statistical significance. One commenter expressed opposition to Methods 3 and 4 as being overly broad, thus allowing into the Program those individuals who do not truly merit Program benefits.

13Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K, Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York City Firefighters After the 9/11 Attacks: An Observational Cohort Study. Lancet. 378(9794):898-905.

Response:The Administrator appreciates the comments provided on the four methods proposed for listing types of cancer as WTC-related health conditions. The final rule adopts the methods outlined in the proposed rule. Under sec. 3312(a)(6) of the PHS Act, the Administrator is permitted to consider a wide range of approaches in adding conditions to the List.

The Administrator agrees with the commenter that Methods 1 and 2, which rely on epidemiologic evidence (Method 1) and established medical relationships between a WTC-related health condition and the development of a type of cancer (Method 2), provide traditional methods for associating exposure and health effects as a means of adding conditions to the List of WTC-Related Health Conditions. However, the Administrator also recognizes that there is a continuum of methods that can be used to establish relationships between exposure and disease: some methods are more definitive and provide a higher level of certainty when establishing an association between exposure and disease outcomes. Adding cancers to the List by Methods 1 and 2 fall in that portion of the continuum of methods that provide greater certainty.

However, Methods 1 and 2 are substantially limited in their ability to provide timely guidance on which types of cancer should be added to the List of WTC-Related Health Conditions to allow the WTC Health Program to provide services to the responders and survivors currently suffering from cancers following exposure to 9/11 agents. Due to the long latency period between exposure and cancer diagnosis for most types of cancer, many epidemiological studies of cancer associated with particular exposures are produced years after a given exposure event. Waiting for definitive, scientifically-unassailable epidemiologic results before adding types of cancer to the List would prevent treatment of currently-enrolled WTC responders and survivors.

In addition, other factors make it difficult to establish definitive associations using traditional epidemiologic methods withinanytimeframe. The number of potentially exposed individuals is small, so the statistical power of any study will be substantially limited. Many of the cancers anticipated in the exposed population are uncommon. Thus, because of the anticipated small numbers of these cancers, detecting statistically significant increases will be difficult and may only be definitively established through a retrospective cohort study conducted decades from now. Upon thorough review of all available information, including peer-reviewed studies, expert opinion, the STAC recommendation, and comments from the public, the Administrator has determined that it is reasonable to acknowledge the limitations of traditional epidemiologic methods and to recognize other methods that incorporate additional sources of information.

Because of the limitations of using epidemiologic studies to establish relationships between exposure and health effects, and the WTC Health Program's responsibility to provide services to affected individuals during their lifetime, the Administrator finds that this unique exposure situation merits the use of methods, in addition to Methods 1 and 2, that provide valuable information about the relationship between exposure and health effects. The Administrator acknowledges that Methods 3 and 4 provide less certainty about the relationship between exposure and cancer than do Methods 1 and 2.

Method 3 relies on identifying those agents categorized by the NTP asknownorreasonably anticipatedto be human carcinogens and by IARC as being known, probable, or possible human carcinogens and havingsufficientorlimitedevidence for causing specific types of cancer in humans. IARC and NTP findings, including IARC's identification of agents associated with specific cancer types, have undergone substantial peer review and/or scientific scrutiny in their development.

Method 4 relies on findings from other sources of information relevant to 9/11 exposures and the potential occurrence of cancer, including the expert judgment and personal experiences of STAC members and comments from the public. The statute allows the Administrator to request a recommendation from the STAC. In this case, the Administrator requested a recommendation from the STAC as well as descriptions of the scientific and/or technical evidence members relied on, the quality of data supporting the evidence, and the methods used. The Administrator found the STAC recommendations and their bases to be reasonable.

Two comments correctly pointed out that the Zeig-Owens study, which was cited as evidence by the STAC, was viewed by the Administrator as not meeting the statistical significance threshold for Method 1. However, the Administrator made the determination to include certain cancers (e.g. thyroid and melanoma) using Method 4 based on a reasonable recommendation from the STAC. The interpretation of statistical significance can vary between knowledgeable observers. The STAC interpreted the Zeig-Owens results as a sound basis for recommending the addition of some types of cancer to the List when the reported statistical significance of findings in the study was near the traditional 95 percent confidence level. The Administrator has determined that the STAC's interpretation is reasonable.

The evidence cited by the STAC for including thyroid cancer and melanoma in their recommendation was that the Standardized Incidence Ratios (SIR) were substantially greater than 1.0 and approached the 95 percent confidence level traditionally used for statistical significance. The STAC also considered other types of cancer that had an elevated SIR in the Zeig-Owens study, such as prostate cancer, and did not recommend them for addition after considering additional information on potential surveillance bias. Thus, the STAC made reasonable arguments for the addition or exclusion of certain types of cancer. The STAC did not limit the basis of its recommendations to a level of statistical significance that would be recognized by all knowledgeable observers of epidemiologic studies.

Finally, the Administrator notes that listing a cancer as a WTC-related health condition does not necessarily mean that a cancer in an individual WTC responder or survivor will be determined to be WTC-related. Each WTC responder and survivor enrolled in the Program will go through a physician's determination and Program certification process to assess whether their individual cancer meets thestatutory definition of a WTC-related health condition. When determining whether an individual's cancer has been contributed to, aggravated by, or caused by their exposures at the 9/11 sites, individual medical history and exposure assessment are used as part of the determination and certification process. Guidelines for physician determinations regarding WTC-related health conditions are jointly developed by the CCEs and the WTC Health Program for all conditions currently on the List. The CCEs and WTC Health Program will develop additional assessment information for use by physicians in making determinations regarding whether an individual's 9/11 exposure may have contributed to, aggravated, or caused their cancer.

Comment:One commenter stated that the STAC's recommendations do not merit the same decision-making weight as Methods 1 and 2 because most of the committee is not rigorously trained in epidemiology and biostatistics.

Response:The Administrator acknowledges the diverse background of the STAC members, but notes that the composition of the STAC was established in sec. 3302(a) of the PHS Act to provide a broad spectrum of backgrounds and expertise to the Administrator. The inclusion of non-scientists on the STAC adds value, knowledge, and perspective to the STAC that might not otherwise be available to the Administrator.

Comment:One commenter was concerned about the potential impact of adding the proposed types of cancer to the List of WTC-Related Health Conditions on the VCF administered by the Department of Justice, and believes that the use of Methods 3 and 4 will overextend the WTC Health Program and the VCF and leave them open to abuse.

Response:The Administrator notes that individuals who are not currently enrolled in the WTC Health Program must first be found to be eligible and qualified to enroll. As discussed above, physician determination and Program certification are two additional steps that must be completed before an individual can receive treatment and monitoring benefits from the Program. Similarly, the VCF employs rigorous standards used to determine individual compensation awards. The Administrator acknowledges the issue of resource limits on the VCF, which is a capped-benefit program. This issue is discussed in Section VII.A below. Further consideration of the potential impact on the VCF is outside the scope of this rulemaking.

Comment:One comment stated that asbestos-related cancers generally have latencies far beyond the 10 years that have passed since September 11, 2001, and that there is great uncertainty in designating asbestos as a cause of stomach or colorectal cancers.

Response:The methodology established in this final rule for adding types of cancer to the List includes identifying those agents categorized by IARC as being known, probable, or possible human carcinogens and havingsufficientorlimitedevidence for causing specific types of cancer in humans, and by the NTP as beingknownorreasonably anticipatedto be human carcinogens. IARC and NTP findings have undergone substantial peer review and/or other scientific scrutiny in their development. These authoritative bodies have categorized all forms of asbestos as known human carcinogens, and IARC has determined there is limited evidence that they cause cancer of the stomach and colon.

When determining whether an individual's cancer has been contributed to, aggravated by, or caused by their exposures at the 9/11 sites, an individual medical history and exposure assessment is used as part of the physician determination and Program certification process. Guidelines for physician determinations regarding WTC-related health conditions are jointly developed by the CCEs and the WTC Health Program for conditions on the List. The CCEs and WTC Health Program will develop additional assessment information for use by physicians in making determinations regarding whether an individual's 9/11 exposure may have contributed to, aggravated, or caused their cancer.

Comment:One comment stated that beryllium and beryllium compounds should be removed as an identified exposure agent for all respiratory cancers listed in Table A. Among other reasons, the commenter indicated that the collapse of the World Trade Center was unlikely to have resulted in emissions of beryllium metal and beryllium compounds above levels found in the natural environment.

Response:The quantitative exposures of individuals at the WTC, particularly during the collapse of the towers and for several days afterward, will likely never be fully known. While the concentrations of beryllium dust in settled dust samples collected from around the WTC sites approximate the concentrations in “background” samples, the exposure conditions that have been described (including thick dust clouds, individuals being coated with dust, and large deposits of dust in homes) result in very different exposures than would be expected to be found in industrial settings or in windblown dirt. The Administrator finds that such conditions are likely to result in large, short-term exposures.

The methodology established in this final rule for adding types of cancer to the List includes identifying those agents categorized by IARC as being known, probable, or possible human carcinogens and havingsufficientorlimitedevidence of carcinogenicity in humans, and by NTP as beingknownorreasonably anticipatedto be human carcinogens. IARC and NTP findings have undergone substantial peer review and/or other scientific scrutiny in their development. These authoritative bodies have categorized beryllium and beryllium compounds as known human carcinogens, and IARC has determined there is sufficient evidence that they cause cancer of the lung.

Comment:Several commenters recognized the important distinction between a cancer being included on the List of WTC-Related Health Conditions and the physician determination and Program certification of a specific cancer in an individual responder or survivor. One comment noted that physicians will need guidance to make a determination that a type of cancer is related to the September 11, 2001, terrorist attacks.

Response:The Administrator recognizes the difficulty inherent in determining whether an individual's cancer can be considered WTC-related. Guidelines for physician determinations regarding WTC-related health conditions are jointly developed by the CCEs and the WTC Health Program for all conditions on the List. The CCEs and WTC Health Program will develop additional assessment information for use by physicians in making determinations regarding whether an individual's 9/11 exposure may have contributed to, aggravated, or caused their cancer.

Comment:One commenter asked that the Administrator exercise authority under the PHS Act to “cover a specific type of cancer in individual cases, notwithstanding the review and determination of when to generally add a type of cancer to the list of covered WTC conditions.”

Response:The Administrator will use his authority under sec. 3312 of the Act and as detailed in 42 CFR 88.13 to cover a condition medically-associated with a condition on the List of WTC-Related Health conditions, as appropriate.

Comment:The Administrator received a number of commentsrequesting the addition of one or more types of cancer. Six commenters asked that cancer of the prostate be added to the List. One commenter asked that cancers of the brain and pancreas also be added to the List. Another commenter asked for the addition of melanoma, thyroid, and non-Hodgkin lymphoma to the List. One of the commenters stated that the Administrator did not address a STAC recommendation to add pre-malignant and myelodysplastic diseases.

Response:The issue of whether to recommend the addition of cancers of the prostate, brain, and pancreas to the List of WTC-Related Health Conditions was considered and discussed by the STAC in the open meeting on March 28, 2012. In those discussions, the STAC considered the available evidence for recommending the addition of cancers of the prostate, brain, and pancreas, including the epidemiologic evidence and the NTP and IARC reviews. Following its deliberation on the matter, the STAC voted not to include prostate, brain, or pancreatic cancer in its recommendation.14 The Administrator concurs with the decision of the STAC and is not adding these cancers to the List of WTC-Related Health Conditions at this time. The addition of these cancers may be reconsidered if additional information on the association of 9/11 exposures and those cancer outcomes becomes available. Regarding the request to add melanoma, thyroid cancer, and non-Hodgkin lymphoma, this final rule specifically includes the addition of melanoma, thyroid cancer, and non-Hodgkin lymphoma to the List of WTC-Related Health Conditions. Finally, the Administrator acknowledges that the STAC's recommendation to add pre-malignant and myelodysplastic diseases was not adopted. This final rule only addresses adding types of cancer to the List. The inclusion of pre-malignant or non-malignant conditions, such as myelodysplastic diseases, may be considered at a later time.

14See STAC (World Trade Center Health Program Scientific/Technical Advisory Committee) Letter from Elizabeth Ward, Chair, to John Howard, MD, Administrator [2012]. This letter is included in the docket for this rulemaking. Seehttp://www.regulations.govandhttp://www.cdc.gov/niosh/docket/archive/docket257.html.

Comment:The Administrator received three comments expressing concern that gaps in data preclude the Administrator from considering cancers and other possible WTC-related health conditions that may affect WTC responders and survivors. Two of the comments expressed concern that the study of female responders and survivors has been lacking. Another commenter also expressed concern for those whose cancer has not been adequately studied or studied at all.

Response:The Administrator is aware of the limitations on the availability of data on cancers and other possible WTC-related health conditions, including the limited information on female responders and survivors. The inclusion of additional types of cancer will be considered at an appropriate time if additional information on the association of 9/11 exposures and cancer outcomes becomes available. The limitations on the availability of data on female responders and survivors will be addressed to the extent possible through analysis of clinical data from medical monitoring examination of responders and survivors, as well as through research studies. The issue of gaps in data regarding non-cancer WTC-related health conditions is outside the scope of this rulemaking.

Comment:Two commenters offered general thoughts about the uncertainty associated with attributing 9/11 exposures to types of cancer, stating that it is not possible to determine which WTC responders and survivors would have been diagnosed with cancer in the absence of 9/11 exposures. These commenters asserted that NYC responders are overcompensated.

Response:For the reasons discussed above, the Administrator has determined that it is appropriate to add the types of cancer in this final rule to the List of WTC-Related Health Conditions in 42 CFR 88.1. While Congress did not include cancers in the statute, the PHS Act directs the Administrator to review all available scientific and medical evidence to determine if cancer or types of cancer should be added to the List and creates various mechanisms for the addition of cancers.15 The Administrator recognizes the inherent difficulty in determining whether an individual's cancer can be considered WTC-related. Guidelines for physician determinations regarding WTC-related health conditions are jointly developed by the CCEs and the WTC Health Program for all conditions on the List. The CCEs and WTC Health Program will develop additional assessment information for use by physicians in making determinations regarding whether an individual's 9/11 exposure may have contributed to, aggravated, or caused their cancer.

15See PHS Act, sec. 3312(a)(5) and (6).

VII. Regulatory Assessment Requirements A. Executive Order 12866 and Executive Order 13563

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

This rule has been determined to be a “significant regulatory action,” under sec. 3(f) of E.O. 12866. Accordingly, this rule has been reviewed by the Office of Management and Budget. The addition of specific types of cancer to the List of WTC-Related Health Conditions by this rule is estimated to cost the WTC Health Program between $2,124,62416 and $5,019,18217 (see Table I) for the first year (2013). Because a portion of responders and survivors are also covered by private health insurance, employer-provided insurance (such as FDNY), or Medicare or Medicaid, only a portion of the costs, those costs representing the uninsured, are societal costs. All other costs to the WTC Health Program are transfers. After the implementation of provisions of the Patient Protection and Affordable Care Act (ACA)(Pub. L. 111-148) on January 1, 2014, all of the costs to the WTC Health Program will be transfers. Transfers from FY 2013 through FY 2016 are expected to be between $12,458,535 and $33,308,060 per annum. The final rule does not interfere with State, local, and Tribal governments in the exercise of their governmental functions.

16Based on a population of 60,000 at the U.S. cancer rate and discounted at 7 percent.

17Based on a population of 110,000 at 21 percent above the U.S. cancer rate and discounted at 3 percent.

Cost Estimates

The WTC Health Program has, to date, enrolled approximately 55,000 New York City responders and approximately 5,000 survivors, or approximately 60,000 individuals in total. Of that total population, approximately 59,000 individuals were participants in previous WTC medical programs and were `grandfathered' into the WTC Health Program established by Title XXXIII. These grandfathered members were enrolled without having tocomplete a new member application when the WTC Health Program started on July 1, 2011 and are referred to in the WTC Health Program regulations in 42 CFR part 88 as “currently identified responders” and “currently identified survivors.” In addition to those currently identified WTC responders and survivors already enrolled, the PHS Act18 sets a numerical limitation on the number of eligible members who can enroll in the WTC Health Program beginning July 1, 2011 at 25,000 new WTC responders and 25,000 new certified-eligible WTC survivors19 (i.e.,the statute restricts new enrollment). Since July 1, 2011, a total of approximately 1,000 new WTC responders and new WTC survivors have enrolled in the WTC Health Program, resulting in only a minor impact on the statutory enrollment limits for new members. For the purpose of calculating a baseline estimate of cancer prevalence only, HHS assumed that this gradual rate of enrollment would continue, and that the currently enrolled population numbers would remain around 55,000 WTC responders and 5,000 WTC survivors. The estimate is further based on the average U.S. cancer prevalence rate and 7 percent discount rate.

18PHS Act, sec. 3311(a)(4)(A) and sec. 3321(a)(3)(A).

19See 42 CFR 88.8(b) for explanation of a certified-eligible survivor.

As it is not possible to identify an upper bound estimate, HHS has modeled another possible point on the continuum. For the purpose of calculating the impact of an increased rate of cancer on the WTC Health Program, this analysis assumes that the entire statutory cap for new WTC responders (25,000) and WTC survivors (25,000) will be filled. Accordingly, this estimate is based on a population of 80,000 responders (55,000 currently identified + 25,000 new) and 30,000 survivors (5,000 currently identified + 25,000 new). The upper cost estimate also assumes an overall increase in population cancer rates of 21 percent due to 9/11 exposure,20 and costs were discounted at 3 percent. The choice of a 21 percent increase in the risk of cancer of the rate found in the un-exposed population is based on findings presented in the only published epidemiologic study of September 11, 2001 exposed populations to date.21 Given the challenges associated with interp